Medtronic’s Infuse® Research Called Into Question

Medtronic has been at the center of a conflict-of-interest scandal following release of a government report that revealed that none of some 13 Medtronic-funded clinical trials reported Infuse® side effects. This, despite that data provided to federal regulators revealed that at least half of all patients treated with Infuse® suffered complications.

The U.S. Senate Finance Committee inquiry initiated in June 2011 probed surgeons paid by Medtronic who had not reported these Infuse®-related complications. As we’ve explained, Medtronic Infuse®—approved by the U.S. Food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients suffering from lower spinal degenerative disease—is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) approved for use in one type of spinal surgery and some dental procedures. The product is used, for the most part, in off-label procedures and the product’s approval was based on research funded by Medtronic.

The very positive studies, pointed out MedPage Today, presented Infuse® as a major breakthrough in spine surgery; however, the significantly manipulated information downplayed the serious complications linked to Infuse® and overstated the bone growth product’s benefits. The Senate report is scheduled to be released this week and will detail how Medtronic employees, some from its marketing department, secretly worked with academic physician authors on11 papers produced between 2002 and 2009.

This type of so-called “ghostwriting” is not illegal, but is largely thought of as a breach of integrity and lacking in transparency, which puts doctors and patients in a position in which they are relying on incomplete, flawed data when determining important medical decisions, noted WebPage Today.

Meanwhile, the Spine Journal, devoted a full issue in 2011 to proving the Infuse® research wrong. “This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Harlan Krumholz, a professor of medicine at Yale University, told MedPage Today when he was advised of the Senate report. “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit. It’s no wonder the public has lost confidence in the drug and device industries,” Krumholz added.

Medtronic faces increased federal scrutiny and mounting legal pressure from the many recipients of Infuse®. In addition to manipulating safety data and misleading surgeons and would-be recipients of the product, Medtronic also actively promoted the use of Infuse® for off-label purposes. Many recipients claim they were never warned of the dangers of Infuse® before it was used in their surgery and, as times goes by, they, along with federal regulators and company shareholders, are learning of the means by which Infuse® reached the market and bolstered the company’s bottom line.

A recent controversy to erupt around Infuse® came when a frequent critic of the product warned that its association with cancer might be stronger than originally thought. In a study presented at the North American Spine Society meeting, Dr. Eugene Carragee reported that his review of a Medtronic-funded study indicated that a higher-dose formulation of Infuse®, known as Amplify, had been linked to a significantly higher number of cancers than were found among those who received a traditional bone graft. Amplify was actually rejected by the FDA because of its association with cancer.

It was Carragee expose that prompted Medtronic to look to Yale University, and Dr. Harlan Krumholz, a doctor Forbes magazine once referred to as “the most powerful doctor you never heard of.” According to a report from the Minneapolis Star-Tribune, Krumholz and his team at Yale will address fundamental questions: Does Infuse® work? Is it safe?

“I’m not seeking to address how the product was marketed,” Krumholz told the Star-Tribune. “I’m just sticking to the science. I’m trying to set in place a new way of doing business.”

While many experts acknowledge the unprecedented nature of the Yale project, and praised its scope, they have little praise for Medtronic’s handling of Infuse®. “I think it’s ridiculous that the company is saying it’s now going to complete an independent study [on Infuse],” Dr. Charles Rosen, a California spine surgeon and founder of the Association for Medical Ethics, told the Star-Tribune. “That implies the previous studies weren’t independent.”